Product Details for NDA 203341
BOSULIF (BOSUTINIB MONOHYDRATE)
EQ 100MG BASE
Marketing Status: Prescription
EQ 400MG BASE
Marketing Status: Prescription
EQ 500MG BASE
Marketing Status: Prescription
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: BOSUTINIB MONOHYDRATE
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N203341
Product Number: 001
Approval Date: Sep 4, 2012
Applicant Holder Full Name: PF PRISM CV
Marketing Status: Prescription
Patent and Exclusivity Information
BOSULIF (BOSUTINIB MONOHYDRATE)
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N203341
Product Number: 001
Approval Date: Sep 4, 2012
Applicant Holder Full Name: PF PRISM CV
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 400MG BASE
Marketing Status: Prescription
Active Ingredient: BOSUTINIB MONOHYDRATE
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N203341
Product Number: 003
Approval Date: Oct 27, 2017
Applicant Holder Full Name: PF PRISM CV
Marketing Status: Prescription
Patent and Exclusivity Information
BOSULIF (BOSUTINIB MONOHYDRATE)
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N203341
Product Number: 003
Approval Date: Oct 27, 2017
Applicant Holder Full Name: PF PRISM CV
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 500MG BASE
Marketing Status: Prescription
Active Ingredient: BOSUTINIB MONOHYDRATE
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N203341
Product Number: 002
Approval Date: Sep 4, 2012
Applicant Holder Full Name: PF PRISM CV
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: BOSULIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N203341
Product Number: 002
Approval Date: Sep 4, 2012
Applicant Holder Full Name: PF PRISM CV
Marketing Status: Prescription
Patent and Exclusivity Information